Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

NCT01336803 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-12-27

Study results available
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Summary

This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.

Conditions

  • Bone Cancer
  • Chondrosarcoma
  • Ewing's Sarcoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Bone Necrosis
  • Bone Sarcoma
  • Osteomyelitis

Interventions

DRUG

Feraheme

5 mg/kg by intravenous (IV) administration

PROCEDURE

Magnetic Resonance Imaging (MRI) scan

Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/

Sponsors & Collaborators

  • Heike E Daldrup-Link

    lead OTHER

Principal Investigators

  • Heike E Daldrup-Link, MD · Stanford University

  • Neyssa Marina, MD · Stanford University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-07-31
Completion
2023-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01336803 on ClinicalTrials.gov